E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The primary aim of this study is the characterization of WB MRI detected untreated MM bone lesions in consideration of the mineralization status and tumor activity using 18F-fluorid-PET/CT and 18F FDG-PET/CT. The second aim of this pilot study is the re-evaluation (after three month) of the detected bone lesion during therapy with the same diagnostic modalities to detect potential changes in the mineralization and tumor activity in MM bone lesions.
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E.1.1.1 | Medical condition in easily understood language |
The aim of this study is the characterization of WB MRI detected untreated MM bone lesions in consideration of the mineralization status and tumor activity.
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of this study is the characterization of WB MRI detected untreated MM bone lesions in consideration of the mineralization status and tumor activity using 18F-fluorid-PET/CT and 18F FDG-PET/CT. |
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E.2.2 | Secondary objectives of the trial |
The second aim of this pilot study is the re-evaluation (after three month) of the detected bone lesion during therapy with the same diagnostic modalities to detect potential changes in the mineralization and tumor activity in MM bone lesions |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ten patients (age: 18-70 years) with diagnosed multiple myeloma stage III by the Durie/Salmon PLUS staging System will be included in the present pilot study. No patients will have received anti-cancer therapy before the start of the study. |
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E.4 | Principal exclusion criteria |
Pregnancy (excluded with a pregnancy test), breast-feeding women, patients that are not able to lie motionless for one hour. Patients suffering on cardiac insufficiency and severe hypertonia. Patients with acute or chronic renal failure. Palliative treatment, recurrent disease, neoadjuvant chemotherapy, other pre-existing malignancies, age > 70 years.
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E.5 End points |
E.5.1 | Primary end point(s) |
Untreated MM bone lesions (osteolytic lesion), show on the one hand a reduced bone turnover (mineralization status) and on the other hand an increased metabolic activity. It is also well known that MM bone lesions change their tumour behaviour under therapy. The hypothesis of this pilot study is that under response to therapy, MM bone lesions show an increased bone turnover (mineralization) and reduced tumour activity. These changes can be detected with 18F-fluoride-PET/CT and 18F FDG-PET/CT WB and MRI (including DWI). We expect to obtain significant differences in the mineralization of MM bone lesions using 18F-fluoride-PET/CT and tumour activity using 18F FDG-PET/CT of the MM bone lesions before and during therapy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study will be performed as a pilot study including 10 patients. |
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E.5.2 | Secondary end point(s) |
The study will be performed as a pilot study including 10 patients. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The study will be performed as a pilot study including 10 patients. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will be performed as a pilot study including 10 patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |